Method and therapeutic device for stimulating vascular activity,production of granulation tissue,and epithelialization in a cutaneous region



United States Patent Ofifice 3,420,233 Patented Jan. 7, 1969 3,420,233 METHOD AND THERAPEUTIC DEVICE FOR STIMULATING VASCULAR ACTIVITY, PRO- DUCTION F GRANULATION TISSUE, AND EPITHELIALIZATION IN A CUTANEOUS REGION Naomi M. Kanof, 2120 Bancroft Place NW., Washington, D.C. 20008 No Drawing. Filed Nov. 24, 1965, Ser. No. 510,161 US. Cl. 128-260 1 Claim Int. Cl. A61m 35/00 ABSTRACT OF THE DISCLOSURE A method of treating a cutaneous ulcer by the application of porous gold leaf, establishing an electrostatic difierential between the ulcer and the gold leaf by applying ethyl alcohol to the site of the ulcer, and then applying the porous gold leaf thereto.

This invention relates to the treatment of ischemic ion-healing ulcers of the skin by the application of gold leaf.

In previous reports (Gallager, I. P., and Geschickter, C. F.: The Use of Charged Gold Leaf in Surgery, JAMA, 189:928, 1964, and Editorial Comment, JAMA, 189:944, 1964) investigations into the use of gold leaf in patching the dura mater was disclosed. The subject arose out of observations of the combination of the metals characteristics of adhesion and to the extreme pliability to minute topographic variations of body tissues, plus its well-known absence of allergic sensitization, of irradiation, and of oxidation. Pilot experiments in which 68 non-healing electrodesiccated cutaneous ulcer sites were dressed with electrostatic gold leaf tended to confirm the original hypothesis that, by the application of gold leaf over cutaneous ulcers, early restitution of tissue could be seen to be taking place. Clinically, it soon became apparent that the Gold leaf, as used herein, means 23K XX Deep Gold Leaf for Glass, which is a standard designation for the partcular type of gold leaf used in this method and which type, supplied by the Hastings Company, of Philadelphia, Pcnnslyvania, can be obtained at artist supply stores. Its thickness is about 0.0000036 inch. This gold leaf is characterized by low content of base metal, a certain porosity, a thickness to permit easy handling and manual application over a skin ulcer so that it closely conforms to virtually all the minute and varied contours of the ulcer and the immediate surrounding area. Substantially thinner gold leaf is difficult to handle because it tends to adhere to the interleaving paper tissues with which it is packaged. Substantially thicker gold leaf does not accommodate to the irregular surface of an ulcer and tends to be too occlusive.

In one controlled experiment, six patients with eleven long-standing non-healing skin ulcers from one to two inches in diameter and unresponsive to usual active therapy were treated with the application of four to eight layers of autoclaved gold leaf (23K XX Deep Gold Leaf for Glass, as aforesaid, and obtained from an artist supply store) after the sites were cleansed with ethyl alcohol. The swabbing of the sites with ethyl alcohol apparently resulted in an increase in electrostatic differential so that the leaf was attracted to the surfaces of the ulcers without the need for stroking with a brush. The sterilized leaf was applied over each ulcer and over the contiguous cutaneous surface. The sites were left uncovered: no other dressing or treatment was used for the duration of the study. The gold leaf remained in situ except in the case of one incontinent Woman with a decubitus ulcer of the buttock (the washing away of the gold by urine every nite necessitate daily reapplication), The sites Were observed and the gold leaf was re-applied at two day intervals. The patients were random, constituting all the available patients with non-healing ulcers at the institution in which the study was performed. A compilation of the study is as follows:

TABLE Patient Size and duration Clinical data Response to gold. leaf 0 ulcers (1) RS Wt 83 yrs 2 ulcers, largest one 2 in. Thrombosis with cellulitis, Pus formation markedly rein diam. 1 month pus, maggots, dissecting duced in 24 hrs; lesions duration. border. dry, epithelialization at (2) ML wt 74 yrs 3 ulcers, each one in. in

diam. 3 month duration.

(3) RE wt 85 yrs Ulcer of dors. of large toe.

3 month duration.

(4) AM wt 67 yrs 2 ulcers, one in. in diam.

6 month duration.

(5) FF Wm 57 yrs 2 ulcers, over one in. in

diam. 5 month duration.

(6) FF wt 73 yrs 1% in.

duratlon.

ulcer over 1 wk Dry crust in 4 days; healing complete in 6 days.

Diabetic; left leg ampu- Smaller ulcer healed in 6 tated; ulcers oi rt. heel. days; larger dry but not completely epitheliized in 10 days. Diabetic; rt. leg ampu- Lesion of 2nd toe not tated; ulcers of 2nd and healed but very vascular;

4th left toes. 4th toe healed in 4 days.

Advanced Parkinsonism; Lesions dry; epithelializagerigbiflus ulcer of rt. tion noted in two days.

application of gold leaf to electrodesiccated skin sites resulted in vascular activity and the production of unusual amounts of granulation tissue. This observation suggested the use of gold in ischemic lesions such as decubitus and arteriosclerotic ulcers of the skin, and resulted in rapid healing in ulcers previously unresponsive to other therapy. Beginning healing was evidenced as early as 2 days after the first application of the gold leaf.

Non-healing cutaneous ulcers means those which do not respond to usual active therapy. Usual active therapy means topical applications of antibiotic and proteolytic agents (including aloe vera). Granulation, as used herein, means tissue which includes blood vessels.

Complete healing was noted within four days (see table) in 6 lesions (four patients) and improvement was present in all treated sites. Complete epithelialization (and remnant discoloration) precluded histo-pathologic studies of these healed lesions. The deepest and widest ulcers of the leg of patient 1, previously surrounded by difiuse erythema, and presenting suppuration, maggot infestation and undermined borders have remained almost completely dry with apparent epithelialization of the borders. It is noteworthy that there has been no surrounding erythema and cellulitis since the third day of treatment. The least responsive lesion is one of two diabetic ulcers in patient 5 whose unhealed lesion appears 3 to have formed more granulation tissue but no epithelialization. A punch biopsy study revealed much granulation tissue in the margin of the lesions of patient 1.

Further studies have revealed curative and beneficial effects of the method when used for varicose ulcers, traumatic ulcers (including burn scars), sclerodermic ulcers, irradiation ulcers, decubitus ulcers, trophic ulcers, neurotic exoriations, erythema induratums, indurated lichenified lesions, and gangrene. In virtually all instances, except with non-painful diabetic ulcers, a marked reduction in pain occurred as soon as the gold leaf was applied. This treatment is also effective in prevention of ulceration, i.e., treatment of superficial bedsores. The treatment has not proved effective in the treatment of ulcers caused by sickle-cell anemia. It is not promising for treatment of normal previously non-pathological sites, such as superficial burns, since it is believed that an excessive amount of granulation tissue would result.

While the precise nature of the functions of the process are not known, it is believed that the application of gold leaf on to ulcers results in stimulation of vascular activity and the production of granulation tissue. The porosity of the gold leaf permits some evaporation of the moisture beneath it, it having been observed that if the leaf is covered by an occlusive substance or dressing, there is interference with healing. While, in some instances, the gold leaf can be applied Without initially swabbing of the site, it is preferred that the site first be swabbed with ethyl alcohol, not only to cleanse it, but also to establish the electrostatic differential which causes the leaf to adhere closely to the irregular surface of the ulcer with little or no further manipulation required.

In its broader aspect, the invention embraces a therapeutic device, i.e., sterile porous gold leaf of about 0.0000036 inch thickness for stimulating vascular activity and the production of granulation tissue at the site of a lesion of the skin. The invention is not limited to the specific method or article, but is intended to cover all substitutions, modifications, and equivalents within the scope of the following claim.

I claim:

1. The method of stimulating epithelialization in a cutaneous region at and proximate to an avascular ulcer other than a cutaneous region fed by blood containing sickle cells by means of sterile porous gold leaf applied thereto which comprises, first establishing an electrostatic differential between the ulcer and the gold leaf by applying ethyl alcohol to the site of the ulcer, and then applying said sterile porous golf leaf in intimate engagement over said ulcer and the cutaneous surface immediately contiguous thereto, and maintaining said gold leaf so applied until epithelialization is stimulated and develops at the ulcer.

References Cited UNITED STATES PATENTS 3,326,213 6/1967 Gallagher 128156 ADELE M. EAGER, Primary Examiner.

US. Cl. X.R. 128156 

